DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a continuation of US Application no. 17/005,800, now US Patent no. 11,839,439, filed 28 August 2020, which is a continuation of US Application no. 16/588,369, now US Patent no. 10,779,898 filed 30 September 2019, which is a continuation of US Application no. 16//215,208, now US Patent no. 10,470,830 which claims the benefit of domestic priority from US Provisional Application no. 62/597,385 filed 11 December 2017.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Manzo et al. (US Publication no. 2008/0046122 -- disclosed by Applicant).
In regard to claim 15, Manzo et al. describe an instrument comprising 152 (robotic surgical manipulator bearing a robotic arm 153, wherein each robot arm includes a surgical tool 101A-101C, para 55, 56, 58-60 and referencing figures 2A and 2B): a shaft 216 (figure 2B, para 63); an end effector positioned at a distal portion of the shaft para 57, but it is taught that an end effector of tool 101A is activated to cauterize or seal tissue; para 64 teaches other end effectors that may located on any of tools 101A-101C; para 111, figure 4A shows tool 101A in greater detail, with an end effector 414 coupled near the distal end of the shaft; and a handle 158 coupled to the shaft and comprising: a first actuator configured to actuate the end effector (para 57, wires 106A,B serves as actuators of the end effectors of tool 101A that actuate the end effector to cauterize or seal tissue); and a second actuator configured to translate the shaft along an insertion axis to control insertion of at least one of the shaft or the end effector into a patient (para 76, other types of drivers or actuators may be provided in the adapter 228 to actuate systems or tools of the robotic surgical instruments 101).
In regard to claim 16, in Manzo et al. the actuation of the first actuator is not affected by actuation of the second actuator (para 60, shaft translates with respect to arm 158; para 64 other motors actuate or articular the end effectors; para 76, separate drivers or actuators actuate tools 101; wherein the separate actuators taught for the end effectors and the separate actuators for the tool 101 are considered to suggest that the end effector is decoupled from the shaft movement.
In regard to claim 17, in Manzo et al. the first actuator comprises at least one cable extending through a redirect pulley (para 157 and 164, figure 9, end effector driven by cable Cl1 comprising first and second cables c1A and C1B connected to spool 920A and driven by pulley 820A).
In regard to claim 18, in Manzo et al. the at least one cable comprises two cables placed in counter tension, the first actuator is configured to create at least one differential in path length of the at least one cable to provide a linear driving of the end effector, and the at least one differential in path length comprises a differential in path length in each of the two cables that are each arranged in opposite directions (para 157 and 164, figure 9, end effector driven by cable Cl1 comprising first and second cables c1A and C1B connected to spool 920A and driven by pulley 820A; para 169, the servomotors 802A-802B to drive the end effectors 812A-812B, a torque differential coupling matrix may be used to provide a translation of torque at the servomotors to the driven pulleys 802A-820B about their respective axis).
In regard to claim 19, in Manzo et al. the redirect pulley is positioned at the distal portion of the shaft or at a proximal portion of the shaft (figure 9 depicts this configuration with cables CL1 extending through the shaft 416 and pulley 820A located at the distal portion of shaft 416).
In regard to claim 20, in Manzo et al. the second actuator comprises a second cable configured to engage with a spool (figure 9, para 153 and 162 shaft is driven by cable CL5 through pulley 828A and idler pulleys 831-832, and pulley 928A, and spool 920A).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Manzo et al. (US Publication no. 2008/0046122 -- disclosed by Applicant).
In regard to claim 1, Manzo et al. disclose a method implemented by an instrument 152 (robotic surgical manipulator bearing a robotic arm 153, wherein each robot arm includes a surgical tool 101A-101C, para 55, 56, 58-60 and referencing figures 2A and 2B) comprising:
actuating an end effector 414 (figure 4A) of the instrument 152 (para 57, but it is taught that an end effector of tool 101A is activated to cauterize or seal tissue; para 64 teaches other end effectors that may located on any of tools 101A-101C; para 111, figure 4A shows tool 101A in greater detail, with an end effector 414 coupled near the distal end of the shaft),
wherein the end effector 414 is positioned at a distal portion of a shaft 101A of the instrument (para 111, figure 4A shows tool 101A in greater detail, with an alternative end effector 414 coupled near the distal end of the shaft); and
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Translating 257 the shaft 216 relative to a handle 158 of the instrument along an insertion axis 215C to control insertion of at least one of the shaft or the end effector into a patient (para 60, 63, and 113).
Manzo et al. is considered to substantially describe the invention as claimed, however does not explicitly teach or describe the method steps as claimed. However, the structure and functional limitations imposed on that structure as disclosed by Manzo et al. is considered to necessarily imply and suggest to one of ordinary skill in the art that the claimed method is an obvious process for its use and as an obvious variation of the intended use of the structure.
In regard to claim 2, Manzo et al. is considered to provide for the actuating of the end effector is decoupled from the translating of the shaft such that the translating of the shaft is unaffected by the actuating of the end effector (para 60, shaft translates with respect to arm 158; para 64 other motors actuate or articular the end effectors; para 76, separate drivers or actuators actuate tools 101; wherein the separate actuators taught for the end effectors and the separate actuators for the tool 101 are considered to suggest that the end effector is decoupled from the shaft movement).
In regard to claim 3, Manzo et al. teach that actuating the end effector comprises changing a length of a first cable within the handle (para 157 and 164, figure 9, end effector driven by cable Cl1 comprising first and second cables c1A and C1B connected to spool 920A and driven by pulley 820A). In regard to claim 4, Manzo et al. teach that manipulating a pulley of a first set of pulleys in the handle to change the length of the first cable within the handle (para 157 and 164, figure 9, end effector driven by cable Cl1 comprising first and second cables c1A and C1B connected to spool 920A and driven by pulley 820A).
In regard to claim 5, Manzo et al. teach that manipulation of the pulley comprises a linear or rotary motion of the pulley (para 119 and 153, the mechanical motion on the pulley to drive the cable is rotational; para 164, rotation of driver pulley 820 moves cables C1A-C1B ).
In regard to claim 6, Manzo et al. teach translating the shaft relative to the handle of the instrument comprises manipulating a second cable to rotate an insertion spool in the handle and cause translation of the shaft relative to the handle (figure 9, para 153 and 162 shaft is driven by cable CL5 through pulley 828A and idler pulleys 831-832, and pulley 928A, and spool 920A).
In regard to claim 7, Manzo et al. teach that instrument is capable of delivery through an incision or natural orifice of a patient to perform a procedure at a surgical site (para 50-51, the surgical system of Manzo et al. is used for open surgery, neurological, laparoscopic arthroscopic, etc, implying insertion to the surgical site through incision).
In regard to claim 8, Manzo et al. disclose a method implemented by an instrument 152 (robotic surgical manipulator bearing a robotic arm 153, wherein each robot arm includes a surgical tool 101A-101C, para 55, 56, 58-60 and referencing figures 2A and 2B), the method comprising: actuating, by a first actuator of the instrument, an end effector of the instrument (para 57, wires 106A,B serves as actuators of the end effectors of tool 101A that actuate the end effector to cauterize or seal tissue; para 111, figure 4A shows tool 101A in greater detail, with an alternative end effector 414 coupled near the distal end of the shaft), wherein the end effector is positioned at a distal portion of a shaft (para 111, figure 4A shows tool 101A in greater detail, with an end effector 414 coupled near the distal end of the shaft); and translating 257 (para 60), by a second actuator of the instrument (para 76, other types of drivers or actuators may be provided in the adapter 228 to actuate systems or tools of the robotic surgical instruments 101), the shaft 216 relative to a handle 158 of the instrument along an insertion axis 215C to control insertion of at least one of the shaft or the end effector into a patient (para 60 and 63). Manzo et al. however do not teach that the handle is releasably coupled to a robotic arm. Manzo et al. show that shaft 216 and tool 101A can be releasably coupled to handle 158 (para 59), however does not teach that handle 158 is releasably coupled from arm 153. However modification in this manner is considered to have been obvious to one of ordinary skill in the art since the courts have held that constructing a formerly integral structure in various, separable elements involves only routine skill in the art. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
In regard to claim 9, Manzo et al. is considered to provide for the actuating of the first actuator (i.e., the end effector) does not affect the actuation of the second actuator (i.e., shaft 101 actuator) (para 60, shaft translates with respect to arm 158; para 64 other motors actuate or articular the end effectors; para 76, separate drivers or actuators actuate tools 101; wherein the separate actuators taught for the end effectors and the separate actuators for the tool 101 are considered to suggest that the end effector is decoupled from the shaft movement).
In regard to claim 10, Manzo et al. teach that the first actuator comprising a first cable extending through a pulley, and actuating by the first actuator comprises changing the length of the first cable using the pulley comprises manipulating the pulley to change the length of the first cable. (para 157 and 164, figure 9, end effector driven by cable Cl1 comprising first and second cables c1A and C1B connected to spool 920A and driven by pulley 820A). In regard to claim 11, Manzo et al. teach that changing the length of the first cable using the pulley comprises manipulating the pulley to change the length of the first cable (para 157 and 164, figure 9, end effector driven by cable Cl1 comprising first and second cables c1A and C1B connected to spool 920A and driven by pulley 820A).
In regard to claim 12, Manzo et al. teach that the first cable extends from a proximal portion of the shaft through the pulley to the distal portion of the shaft (Figure 4a shows elongate shaft 416 with distal end effector 414 and proximal end 401; figure 4C show pulleys 435A-B with cable loops in the proximal end 401, and figure 4G shows the cables 437 passing through the elongate shaft 416 to the distal end effector; figure 9 also depicts this configuration with cables CL1 extending through the shaft 416)
In regard to claim 13, Manzo et al. teach that the second actuator comprises a second cable configured to engage with an insertion spool (figure 9, para 153 and 162 shaft is driven by cable CL5 through pulley 828A and idler pulleys 831-832, and pulley 928A, and spool 920A).
In regard to claim 14, Manzo et al. teach that the instrument is capable of delivery through an incision or natural orifice of a patient to perform a procedure at a surgical site (para 50-51, the surgical system of Manzo et al. is used for open surgery, neurological, laparoscopic, arthroscopic, etc, implying insertion to the surgical site through incision).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of U.S. Patent No. 11,839,439. Although the claims at issue are not identical, they are not patentably distinct from each other because the presently recited method steps are considered an obvious process of using the structure of the medical device and computer readable media of the ‘439 patent. Each of independent claims: 1 in view of claims 8-12, 13 in view of 20, 31, and 34 in view of 37-38 recite the features of the shaft and end effector, wherein the shaft is configured to move by translation relative to the handle of the instrument. The structure and function of the invention claimed in the ‘439 patent is considered suggestive of use in the manner as presently claimed. Therefore the present invention is not considered a patentably distinct method of use over the ‘439 patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 10,779,898. Although the claims at issue are not identical, they are not patentably distinct from each other because the presently recited method steps are considered an obvious process of using the structure of the medical device and computer readable media of the ‘898 patent. Each of independent claims: 1 in view of claims 2-5, 15 in view of claims 16-18, 21, and 25 recite the features of the shaft and end effector, wherein the shaft is configured to move by translation relative to the handle of the instrument. The structure and function of the invention claimed in the ‘898 patent is considered suggestive of use in the manner as presently claimed. Therefore the present invention is not considered a patentably distinct method of use over the ‘898 patent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 10,470,830. Although the claims at issue are not identical, they are not patentably distinct from each other because the presently recited method steps are considered an obvious process of using the structure of the medical device and computer readable media of the ‘830 patent. Each of independent claims: 1 in view of claims 2-5, 15 in view of claims 16-18, 21, and 25 recite the features of the shaft and end effector, wherein the shaft is configured to move by translation relative to the handle of the instrument. The structure and function of the invention claimed in the ‘830 patent is considered suggestive of use in the manner as presently claimed. Therefore the present invention is not considered a patentably distinct method of use over the ‘830 patent.
Conclusion
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 18 February 2026